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ISRCTN
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ISRCTN06900747
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ClinicalTrials.gov identifier
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Public title
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Comparison of two physiotherapy rehabilitation programmes on the exercise capacity in patients with severe pulmonary hypertension
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Scientific title
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Comparison of two physiotherapy rehabilitation programmes on the exercise capacity in patients with severe pulmonary hypertension: a randomised study
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Acronym
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Rehab PH
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Serial number at source
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EKBB 200/09
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Study hypothesis
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An endurance or/and resistance training improves the exercise capacity and quality of life of patients with severe pulmonary hypertension
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Lay summary
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Ethics approval
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The local ethics committee, Basel, Switzerland approved in June 2009
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Study design
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Prospective randomised interventional trial
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Pulmonary hypertension
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Participants - inclusion criteria
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1. Patients with pulmonary hypertension diagnosed by right heart catheterisation (mean pulmonary pressure [PAPm] > 25 mmHg)
2. New York Heart Association (NYHA) III - V
3. Walking distance (6-minutes walk test) > 150 meters
4. Patients with stable conditions on PH-related medication (single, double or triple therapy)
5. In stable condition for at least 3 months
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Participants - exclusion criteria
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1. Skeletal or muscular restrictions which make the training impossible
2. New occurrence of syncope
3. Concomitant neurological diseases
4. Patients with neoplastic diseases
5. Mental disability making a proper evaluation of the study impossible
6. Age > 18 years < 85
7. Rapid fatal disease
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Anticipated start date
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01/07/2010
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Anticipated end date
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30/06/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet.
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Target number of participants
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36
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Interventions
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Intervention group 1: - endurance training: twice a week, 60 minutes, over 12 weeks
Intervention group 2: - resistance training: twice a week, 60 minutes, over 12 weeks
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Primary outcome measure(s)
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Change in walking distance (6-minutes walk test) after 12 weeks of training and 12 weeks follow up
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Secondary outcome measure(s)
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1. Change in VO2 submax (mobile spiroergometry) after 12 weeks of training and 12 weeks follow up
2. Change in scores for quality of life (SF-36 questionnaire) after 12 weeks of training and 12 weeks follow up
3. Change in scores (MRC-Dyspnoea scale) after 12 weeks of training and 12 weeks follow up
4. Change in daily activity measured with an accelerometer AiperMotion 320 after 12 weeks of training and 12 weeks follow up
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Sources of funding
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University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research (from research funds of Prof M Tamm)
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Trial website
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Publications
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Contact name
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Prof
Daiana
Stolz
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Address
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University Hospital Basel
Pneumology
Petersgraben 4
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City/town
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Basel
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Zip/Postcode
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4031
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Country
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Switzerland
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Sponsor
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University Hospital Basel (Switzerland)
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Address
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University Hospital Basel
Pneumology
Petersgraben 4
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City/town
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Basel
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Zip/Postcode
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4031
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Country
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Switzerland
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Date applied
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27/05/2010
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Last edited
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15/07/2010
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Date ISRCTN assigned
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15/07/2010
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